Bioequivalence Study of Sulfadoxine/Pyrimethamine 500 mg/25 mg Dispersible Tablets in Healthy subjects.

Not Applicable

• Registration Number: CTRI/2018/11/016376
• Lead Sponsor: Rena Exports

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

A subject should fulfill all the following

1) criteria to be included in the present study:

Willing to provide written informed consent for participation in the study and an ability

to apprehend the nature and purpose of the study;

2) Willing to be available for the entire study and to comply protocol requirements;

3) Normal, healthy, adult, human subject of 18-45 years (both inclusive) of age;

4) Body mass index in the range of 18.50-30.00 kg/m2 (both inclusive); with minimum of

45 kg weight.

5) Normal health status as determined by baseline medical and medication history, at the

time of screening and vital signs (supine/sitting blood pressure, pulse rate, respiratory

rate and axillary temperature) measurements and clinical examination at the time

screening as well as check-in during study;

6) With normal or clinically non-significant laboratory values as determined by

hematological and biochemistry tests and urine analysis;

7)With a normal or clinically non-significant 12-lead ECG;

8) Non-smokers and willing to abstain from chewing any tobacco containing product at

least 72.00 hours prior to dosing and throughout the sampling points;

9) Non-alcoholic;

In case of female subjects:

10) Negative urine pregnancy test during screening and negative serum β-HCG test at

the time check-in;

11) Female subjects with child bearing potential or those within their first two years of

onset of menopausal syndrome must either abstain from sexual intercourse, or using

acceptable methods of birth control for at least 15 days before 1st dosing till 15 days

post last-dose/entire study period. (Acceptable birth control methods include barrier

methods such as diaphragm/condom with spermicide or who are surgically sterile

(bilateral tubal ligation, bilateral oophorectomy or hysterectomy has been

performed).

Exclusion Criteria

A subject fulfilling any one of the following criteria should be excluded from the study:

1) Any medical or surgical conditions, which might significantly interfere with the

functioning of gastrointestinal tract and of bloodâ??forming organs;

2) Significant history or current evidence of malignancy or chronic - infectious,

cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic

(endocrine), hematological, gastrointestinal, immunological or psychiatric diseases, or

organ dysfunction;

3) Subjects with rare hereditary problems of galactose intolerance, the Lapp lactase

deficiency or glucose-galactose malabsorption OR Subject has a history of severe

allergy to milk protein;

4) Any major illness or hospitalized within 90 days prior to the dosing;

5) Any other clinical condition like diarrhea or vomiting within 3 days prior to dosing;

6) Requiring medication for any ailment having enzyme-modifying activity in previous

one month, prior to drug administration day and throughout the study duration;

7) Use of any depot injection or an implant of any drug within 3 months prior to dosing

and throughout the study duration;

8) Use of any prescribed medication (including herbal drugs and vitamin supplements) 30

days or within 5 half-lives of the drug, whichever is longer prior to dosing and

throughout the study duration;

9) Use of any OTC products within 14 days or within 5 half-lives of the drug, whichever is

longer prior to dosing in the study duration and throughout the sampling time points;

10) History or presence of significant gastric and/or duodenal ulceration;

11) Difficulty in swallowing solids like tablets or capsules;

12) Use of any recreational drug or history of drug addiction;

13) Participated in any clinical investigation requiring repeated blood sampling, blood

donation, or have blood loss of >500 mL in past 8 weeks or participated in any clinical

study within the 90 days prior to dosing;

14) Positive alcohol breath or urine drug of abuse tests during check-in in the study;

15) Consumption of xanthine or its derivative containing food or beverages (e.g.

chocolates, tea, coffee or cola drinks) within 48.00 hours prior to dosing in the study

and throughout sampling time points;

16) Consumption of grapefruit or its juice within 72.00 hours prior to dosing in the study

and throughout sampling time points;

17) Positive test for Human Immunodeficiency Virus (HIV) type I/II antibodies or

Hepatitis B surface antigen (HBsAg) or Hepatitis C virus antibodies;

18) Female subject whose menstruation cycle coincides with the study duration;

Lactating or nursing female subjects;

19) Female subjects using hormonal contraceptive (either oral/implants);

20) History of allergy or hypersensitivity intolerance to Sulfadoxine/ Pyrimethamine (API)

or its formulation excipients which, in the opinion of an investigator, would

compromise the safety of the subject or the study;

21) History of difficulty in accessibility of veins in arms.

Study & Design

• Study Type: BA/BE
• Study Design: Not specified